CDER Emerging Drug Safety Technology Program

The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence (AI) and emerging technologies within pharmacovigilance (PV) to advance drug safety and lifecycle management. This program fosters communication with the pharmaceutical industry to enhance the FDA’s understanding of AI-enabled tools and other technologies in PV, aiming to assess their performance, […]

The EU AI ACT: Implications for the Medical Device Industry

The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]

ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs

In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first lawsuit in an attempt to block the implementation of the Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs). The contentious Final Rule, which aims to regulate LDTs, has sparked heated debates within the healthcare and regulatory […]

MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the future of regulatory oversight with the launch of the AI Airlock initiative, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD). This groundbreaking endeavor marks a significant leap forward in harnessing the […]

MHRA Proposes Stringent Requirements for High-Risk In Vitro Diagnostic Devices (IVDs)

In a bid to bolster patient safety and enhance regulatory oversight, the Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled proposed requirements for high-risk in vitro diagnostic devices (IVDs) in the United Kingdom. The proposed measures, outlined in a recent consultation document, represent a significant step towards aligning UK regulatory standards with international best […]

Upcoming Regulation 2023/607 Transitional Provision Deadlines for MDR

On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated notified bodies and the associated over-capacities, and the imminent threat of significant shortages of necessary medical devices available on the market, the EU set forth Regulation 2023/607, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for […]

Regulatory Science Tools Catalog

On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, […]

CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices

FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. The Chemicals List for Analytical Performance (CLAP) tool is chemical dataset intended to help analytical laboratories demonstrate their ability […]

Navigating the EU Clinical Trials Regulation (CTR)

The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation of clinical research within the EU. Enacted to streamline and harmonize the conduct of clinical trials across member states, the CTR aims to enhance patient safety, promote transparency, and facilitate the timely initiation and completion of clinical research. As the […]

The EU IVDR Impact on Clinical Trials

The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]